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Details for New Drug Application (NDA): 070984

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NDA 070984 describes HALOPERIDOL, which is a drug marketed by Solopak, Smith And Nephew, Sandoz, Morton Grove, Frontida Biopharm, Watson Labs, Teva, Marsam Pharms Llc, Duramed Pharms Barr, Teva Pharms, Alpharma, SCS, Royce Labs, Lederle, Claris, Cycle Pharms Ltd, Par Pharm, Teva Pharms Usa, Vintage, Pharm Assoc, Sagent Pharms, Mylan Labs Ltd, Quantum Pharmics, West-ward Pharms Int, Silarx, Purepac Pharm, Gland Pharma Ltd, Sun Pharm Inds, Mylan, Zydus Pharms Usa, Abraxis Pharm, Fresenius Kabi Usa, Hospira, and Actavis Mid Atlantic, and is included in one hundred and four NDAs. It is available from thirty suppliers. Additional details are available on the HALOPERIDOL profile page.

The generic ingredient in HALOPERIDOL is haloperidol decanoate. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

Summary for NDA: 070984

Tradename:
HALOPERIDOL
Applicant:
Watson Labs
Ingredient:
haloperidol
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Mar 6, 1987TE:RLD:No


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